The business, in plain English
A medicine cabinet with one very large bottle in it
Merck (MSD outside the United States and Canada) discovers, makes and sells prescription medicines and vaccines, and through its Animal Health division, medicines for pets and farm animals. In 2025 it sold $65.0bn: $58.1bn of human medicines and vaccines and $6.4bn of animal health. It employs about 75,000 people and is based in Rahway, New Jersey.
One product dominates. Keytruda is a cancer immunotherapy: an antibody that takes the brakes off the patient's own immune system so it can attack tumours. Since its approval in 2014 it has been approved for dozens of uses, from lung cancer, its largest, to melanoma, kidney, bladder, breast and others, and it became the best-selling medicine in the world. In 2025 it brought in $31.7bn, 49% of Merck's sales. Merck does not publish profit by product, but a medicine of that size, made at that scale and sold at that price, probably earns well over half of the company's profit.
The second franchise is vaccines: Gardasil, which prevents the cancers caused by HPV ($5.2bn in 2025, down from $8.6bn in 2024 after sales to China stopped), childhood vaccines and Capvaxive for adult pneumonia. Then a long list of other medicines: Winrevair for a rare lung disease, Welireg for kidney cancer, shares in Lynparza and Lenvima, and older drugs like Januvia and Bridion that have just lost their patents.
Drug patents last about twenty years from filing, and the useful selling life is usually ten to fifteen. When a patent ends, cheaper copies arrive and sales of the original fall by most of their value within a few years. Every large drug company is therefore running to stand still: it must discover or buy new medicines faster than the old ones expire. Merck's problem is that the thing about to expire is half the company.
★★ The cliff
2028, 2029 and the years after: three blows at once
Merck's 2025 annual report gives the dates plainly. Keytruda's key patents expire in 2028 in the United States and China, 2031 in the main European markets and 2032–33 in Japan. Two further US patents run to 2029 because of extensions, and Merck expects to have to defend them in court. Biosimilar copies are already in development by at least a dozen companies, including Amgen, Samsung Bioepis, Celltrion, Sandoz and Formycon, and have launched in a few small markets such as Argentina; Merck expects their effect to be immaterial in 2026.
The second blow comes from Washington. Under the Inflation Reduction Act, Medicare negotiates prices for the most expensive medicines. Keytruda was not chosen for 2028, but Merck's latest 10-Q says it expects Keytruda to be selected in 2027, with the government price taking effect on 1 January 2029, and a pending rule may sweep the new under-the-skin version in with it. Merck lost its constitutional challenge to the programme on 24 August 2026. In Germany, a health-spending reform effective mostly from January 2027 will, in Merck's words, exert significant downward pressure on revenue there, "particularly with respect to KEYTRUDA".
The third blow is competition. A new class of drugs that combine a PD-1 blocker, Keytruda's mechanism, with a VEGF blocker in one molecule is being tested against Keytruda in lung cancer, Keytruda's largest use. Summit and Akeso's ivonescimab has an FDA decision date of 14 November 2026, the day of this report, for a narrower use; Pfizer, BioNTech and Bristol Myers have their own versions in late trials. If lung-cancer treatment moves to these drugs between 2028 and 2030, it would arrive at exactly the moment the copies and the government price do.
| The defence | What Merck is doing | Our reading |
|---|---|---|
| Keytruda Qlex | An under-the-skin version (approved September 2025) that takes minutes instead of a half-hour infusion, US patent to 2043. $830m in Q3 2026, 9.7% of the Keytruda family; target 30–40% of US use by end-2027. | ✓ The main shield |
| Halozyme's patents | Halozyme says Qlex uses its enzyme technology. US patent board found every challenged claim unpatentable; but a German injunction (December 2025) and a Dutch one (7 October 2026) block Qlex in several European countries. Hearings 19 Nov (Germany), 30 Nov (UK), 2 Dec (Italy). | ◆ Europe at risk |
| New combinations | Plans to replace today's Keytruda regimens with combinations built on Qlex: sac-TMT (an antibody-drug conjugate), a KRAS drug, and its own PD-1×VEGF bispecific (MK-2010, phase 3 from H1 2027). | ◆ Years away |
| The 2029 patents | Two US patents extended to 2029, expected to be litigated. | ◆ Months, not years |
What management says. The chief financial officer, Caroline Litchfield, said on 29 October 2026 to expect "a shallow dip in revenues" after the IRA price and the loss of exclusivity, followed by a quick return to growth, with earnings "probably" mirroring that. Analysts' consensus, which is thin beyond 2027, shows no dip at all: earnings per share of about $9.9 in 2028, 2029 and 2030. That is the most optimistic reading of the cliff we have seen. Our valuation in Part XI does not assume it.
★ How $73 became $148
Earnings stood still; belief doubled
| Date | What happened | The shares |
|---|---|---|
| 4 Feb 2025 | 2024 results; Gardasil shipments to China paused "through at least mid-year" (in the end, none in 2025). | −9.1% |
| 14 May 2025 | Closing low, in the weeks of the US "most-favoured-nation" drug-pricing order and tariff threats. About 8 times earnings at the low. | $73.47 |
| 30 Sep – 1 Oct 2025 | Pfizer's pricing and tariff deal with the White House lifts the whole sector. | +6.8%, +7.4% |
| Nov 2025 | Rotation into healthcare; Cidara purchase announced (14 Nov); European approval of Keytruda's under-the-skin version. | about +22% |
| 19–22 Dec 2025 | Merck's own three-year pricing agreement with the US government: Januvia via TrumpRx, Medicaid discounts, most-favoured-nation prices for new launches; tariffs deferred three years. | +3.6% |
| 21 Apr 2026 | A kidney-cancer trial of a Welireg combination fails. | −3.9% |
| 16 Jul 2026 | FDA approves Lipfendra (enlicitide), the first cholesterol-lowering PCSK9 pill. | +3.3% |
| 19 Aug 2026 | The melanoma vaccine: intismeran, with Moderna, plus Keytruda cuts the risk of relapse by 42% (hazard ratio 0.58) in a phase 3 trial. | +12.6% |
| 25 Aug 2026 | Record close. | $156.45 |
| 29 Oct 2026 | Third quarter beats; guidance raised; the CEO says Merck expects to raise its "$70 billion" pipeline figure. | +3.8% |
| 13 Nov 2026 | Our price. | $147.76 |
In May 2025 the market was pricing Merck as if the cliff would be a fall. It had reasons: the China Gardasil collapse, the US government's threats on prices and tariffs, and two years to go before Keytruda's patent ended. At $73.47 the shares traded at about 8 times earnings, the lowest in at least a decade.
Since then three things happened. The policy threats were settled by a deal that cost Merck less than feared and postponed tariffs. A string of trial results went right: the melanoma vaccine, Lipfendra, sac-TMT in endometrial cancer, Winrevair's growth. And investors moved back into pharmaceutical stocks as a group. Meanwhile, the earnings did not move: Merck earned $8.98 a share before one-off items in 2025 and will earn about $8.85 in 2026 by the same measure. The share price doubled because the market changed its mind about what happens after 2028, not because anything happened before it. That is a legitimate reason for a price to move. It is also the kind of move that reverses when a trial fails.
How it makes money
Keytruda, a fading vaccine franchise, a growing tail, and the animals
How profitable. In 2025 Merck's pharmaceutical segment earned $45.8bn of segment profit on $58.1bn of sales, a 79% margin, before most of the research budget, which Merck keeps at the centre. Animal Health earned $2.1bn on $6.4bn. If Keytruda earns only the average margin of the pharmaceutical segment, it accounts for about 52% of total segment profit; a mature, high-priced biologic probably earns more than the average. Either way, the 2028–29 cliff is about more than half of the company's earning power.
The vaccine lesson. Gardasil shows how fast a franchise can change. It sold $8.6bn in 2024 and $5.2bn in 2025, because sales to China, through the distributor Zhifei, stopped: demand fell, a Chinese-made nine-valent vaccine was approved in May 2025, and Merck shipped nothing to China in 2025. A revised contract was signed in April 2026; revenue from it will be immaterial this year. In the US, a federal court in March 2026 paused a government recommendation for a single dose of HPV vaccine instead of two; Merck says any effect is not material. Vaccines depend on public-health policy, and public-health policy in the US has become less predictable.
A warning in the third quarter. About $550m of the quarter's $18.1bn of sales came from the timing of US purchases, which Merck expects to unwind in the fourth quarter. The third-quarter beat was real but smaller than it looked.
The moat
A moat made of patents, which by definition expire, and of the skill to make new ones
A drug company's moat is unusual: the strongest part of it, the patent, is a legal monopoly with a known expiry date. What lasts is the machinery that produces the next patent. We test both.
| The claim | The evidence | Our verdict |
|---|---|---|
| Keytruda's patents | A monopoly on the world's largest medicine until 2028 (US, China), 2031 (EU), 2032–33 (Japan); Qlex to 2043 in the US. | ◆ Strong, with a date |
| Oncology know-how and data | Keytruda's dozens of approvals and hundreds of trials give Merck the data and the relationships with cancer doctors to build the next combinations faster than a newcomer. | ✓ Real |
| Vaccines manufacturing | Few companies can make complex vaccines at global scale. But Gardasil showed the franchise depends on policy and on China. | ◆ Real, but exposed |
| Research and dealmaking | Winrevair (from Acceleron) and Lipfendra (in-house) are genuine successes; several 2026 trials failed (Welireg combination, two Keytruda trials, a lung-cancer filing withdrawn). | ◆ Average for big pharma |
| Animal Health | Bravecto and livestock vaccines: a durable, branded, slower business with long product lives and no cliffs. | ✓ Steady |
Our verdict is a moat of 7, of the intangible-asset kind, and its trend over the next five years is narrowing by construction: half the company's profit sits behind patents that end in 2028–2033. What would widen it again is the replacement portfolio becoming as broad as Keytruda's indications. Merck's scientists have done this before; Keytruda itself came to Merck with Schering-Plough in 2009, from research begun at Organon, and was nearly licensed away. The record of big pharmaceutical companies in replacing their largest product without a fall in earnings is mixed: AbbVie, after Humira, is the best recent example, and even AbbVie's earnings dipped for two years.
- That Keytruda Qlex reaches 30–40% of US use by the end of 2027 and survives the Halozyme patent fights in Europe, so that a large part of Keytruda's sales stays protected well beyond 2028.
- That the replacement portfolio (Winrevair, Lipfendra, sac-TMT, the melanoma vaccine, the flu antiviral from Cidara, the leukaemia pill from Terns, Merck's own PD-1×VEGF bispecific) produces roughly $20bn a year of new sales by 2030, so that earnings per share dip only briefly and reach about $11.50 by 2030.
- That the market then pays about 18 times earnings, above Merck's ten-year range of about 8 to 17.5 times, for a company that has just come through its cliff.
★ The replacement
More than $60 billion of purchases, a $70 billion promise, and which bets have paid
Robert Davis, Merck's chief executive, set out the case on 3 February 2026: "line of sight to over $70 billion of potential commercial opportunity by the mid-2030s", $20bn more than a year earlier and more than double the $35bn of Keytruda sales that analysts expect at the 2028 peak. Davis added that the figure was not risk-adjusted: it is what the pipeline could sell if everything works. On 29 October Davis said Merck expects to raise it. An owner should treat a non-risk-adjusted figure as an upper bound. In pharmaceutical research, a drug entering phase 3 trials has historically had something like a one-in-two chance of approval, and an approved drug rarely reaches the peak sales forecast for it.
| Product | What it is | Where it stands (Nov 2026) | Our reading |
|---|---|---|---|
| Winrevair | For pulmonary arterial hypertension (from Acceleron, $11.5bn, 2021). | $694m in Q3 2026, +93%; ~$2.8bn a year; US data exclusivity to 2036. | ✓ Paid |
| Lipfendra (enlicitide) | The first PCSK9 cholesterol pill; LDL cholesterol −56% to −59% versus placebo. | FDA-approved July 2026; list price $10.50 a day. Outcomes trial still to come. | ◆ Promising |
| Intismeran | A personalised cancer vaccine with Moderna, given with Keytruda after melanoma surgery. | Phase 3: relapse risk −42% (HR 0.58). Filing expected; other cancers in trials. | ◆ Promising |
| Sac-TMT | An antibody-drug conjugate (from Kelun-Biotech). | Endometrial cancer: death risk −32%; FDA decision by 15 June 2027. | ◆ Promising |
| Ohtuvayre | A COPD inhaler (from Verona, $10.4bn, 2025). | $519m in nine months of 2026; ~15 times its sales paid. | ◆ Must grow fast |
| MK-1406 (Cidara) | A once-a-season flu antiviral ($9.2bn, January 2026). | Phase 3. $9.0bn expensed at once as research. | ◆ Binary |
| MK-4208 (Terns) | An oral drug for chronic myeloid leukaemia ($6.8bn, May 2026). | Phase 1/2. $5.7bn expensed at once. | ◆ Binary |
| Tulisokibart (Prometheus) | For ulcerative colitis and Crohn's disease ($11.0bn, 2023). | Phase 3; one other use failed. | ◆ Unproven |
Our reading. Of the eight largest purchases since 2021, about $51bn in total, only Acceleron has clearly earned its price so far; three others have products on the market that must still grow into their cost, and the rest are trials. That is not a criticism peculiar to Merck: buying late-stage science is how large drug companies replace their patents, and the prices are high because everyone is doing it at once. It does mean that a large part of today's share price rests on outcomes that have not yet happened. A Buffett-style test is whether the $60bn will produce something like $5–6bn a year of after-tax profit in the 2030s. Today, one deal clearly passes.
The competition
Copies, a new class of cancer drugs, a Chinese HPV vaccine and an old rival in pneumonia
| Rival | Where it meets Merck | The latest | Threat |
|---|---|---|---|
| Keytruda biosimilars | Copies of Keytruda from Amgen, Samsung Bioepis, Celltrion, Sandoz, Formycon and others: at least 13 programmes. | Launched in a few small markets; US entry from 2028, Europe from 2031. | ✗ Certain |
| PD-1×VEGF bispecifics | Summit/Akeso's ivonescimab, Pfizer/3SBio's PF-08634404, BioNTech/BMS's pumitamig: one molecule hitting Keytruda's target and a second one. | Ivonescimab's FDA decision due 14 Nov 2026 (no outcome at publication; the FDA has said it needs a significant survival benefit). Pfizer's showed longer progression-free survival than a PD-1 combination in a phase 2 (ESMO, October 2026). | ✗ The real question |
| Chinese HPV vaccine | A domestic nine-valent vaccine approved in China in May 2025. | Merck sold no Gardasil in China in 2025; immaterial revenue in 2026. | ◆ China lost |
| Pfizer's Prevnar | Adult pneumococcal vaccines, where Capvaxive competes. | Capvaxive US sales −13% in Q3 2026 on lower vaccination and price. | ◆ Hard market |
| PCSK9 rivals | Injectable PCSK9 drugs (Amgen and others) for a decade; an oral rival from AstraZeneca in phase 3. | Lipfendra is first as a pill; the injectables are established. | ◆ A race |
The pattern. Keytruda's competitors used to be other PD-1 drugs that it outsold by a wide margin. The threat now is different in kind: a drug that does what Keytruda does and something more, tested head-to-head against Keytruda in lung cancer. Merck's response is to make its own bispecific and to move Keytruda's users to combinations built on Qlex before the copies arrive. Whether that works will be known only between 2027 and 2030.
Across our board. We said AbbVie was "fairly priced — start small, add near $235" in September: AbbVie had already come through the Humira cliff and showed its replacements selling. Pfizer, in August, was "not a melting ice cube, not a compounder either". Merck sits between them: further from its cliff than Pfizer, but with the cliff still ahead rather than behind, as AbbVie's now is. At 16.5 times earnings, it is priced closer to AbbVie than to Pfizer.
Management, capital & governance
A former finance chief at the helm, a buyback that continues, and insiders who sold at $118
Integrity. Merck's disclosure is thorough: its 10-Q gives the exact patent dates, the IRA expectations, every lawsuit and every injunction, and its management names the dip ahead rather than hiding it. Two things we would change. Merck's "non-GAAP" earnings, unlike most companies', include the cost of research bought in acquisitions, which made 2026 guidance of $2.77–2.82 a share look like a collapse when the business was flat; Merck is right to include it, because buying research is a real cost, but owners need both figures. And the "$70 billion" pipeline number, not risk-adjusted, is a sales pitch, not a forecast.
Capital allocation. Merck spends its cash in four directions: the dividend (about $8.4bn a year), buybacks ($3bn planned in 2026, $5.1bn left under the current authorisation), research, and deals. From 2016 to 2025 it bought back $31.2bn of stock and reduced its diluted share count by about 10%. Its debt rose from $24.8bn in 2016 to $53.8bn in September 2026, mostly to pay for the deals. The question for an owner is whether paying 10 to 15 times sales for companies with one promising medicine is a good use of Keytruda's cash. Acceleron says yes; the rest have yet to answer.
Governance. The roles of chairman and chief executive are combined, as at many large US companies. The board added a director on 1 November 2026. Pay is moderate for the sector; performance shares are linked half to earnings and half to relative shareholder return. No insider bought shares in the open market in the last twelve months.
The numbers
A strong balance sheet with more debt than before, two kinds of earnings, and a screen with six faults
At 30 September 2026 Merck had $53.8bn of debt and $11.3bn of cash and investments: net debt of about $42.5bn. On reported earnings, which include $14.7bn of research bought with Cidara and Terns and written off at once, that is about 3.0 times EBITDA; adding those one-off charges back, about 1.5 times. Merck's new bonds in May 2026 were rated Aa3 by Moody's and A+ by S&P, both stable. Goodwill and other intangible assets ($46.4bn) exceed shareholders' equity ($44.9bn), so tangible equity is slightly negative, which is normal for a company that has bought its pipeline. Interest cost rose to $1.55bn in the first nine months of 2026, from $0.95bn a year earlier.
Two kinds of earnings. Merck reports earnings under accounting rules (GAAP) and its own "non-GAAP" measure, which removes amortisation and restructuring but, unusually, keeps the cost of research bought in acquisitions. In 2026 that cost is $6.05 a share. So non-GAAP EPS for 2026 is guided at $2.77–2.82, GAAP lower still, and the underlying business earns about $8.85. All three numbers are true. Only the last tells you what the business earns in a year; the first two tell you what management spent on the future.
| What the screen shows | What is wrong, and the number to use |
|---|---|
| 2025: revenue $64.9bn, R&D $12.5bn, cost of sales $18.2bn | The annual and quarterly 2025 rows do not match Merck's 10-K. Actual: revenue <b>$65.01bn</b>, R&D <b>$15.79bn</b>, cost of sales <b>$16.38bn</b>. Margins and R&D intensity computed from the feed are off by several points. |
| Q1 2026 gross margin 81.9% | Cost of sales was taken from the non-GAAP table. The reported (GAAP) gross margin was <b>74.2%</b> (cost of sales $4,195m, not $2,944m). |
| Q3 2026 depreciation and amortisation: 0 | About <b>$1.78bn</b>, from the 10-Q's cash-flow statement. The zero also distorts EBITDA and every ratio built on it. |
| Revenue by segment: $107bn for 2025 | Two ways of splitting sales are added together, and 2023 is missing. Actual 2025: <b>$65.01bn</b> = Pharmaceutical $58.14bn + Animal Health $6.35bn + other $0.52bn. |
| P/E 149×; payout ratio 341% | Both use GAAP earnings after $14.7bn of acquired research written off at once. On underlying earnings (~$8.85): P/E about <b>16.7×</b> and payout about <b>38%</b>. The screen shows no warning. |
| Dividend summary empty; head office 'Kenilworth' | Four dividends were paid in the last twelve months (<b>$3.40</b>); the summary shows none. Merck's head office is in <b>Rahway</b>, New Jersey; our desk note is out of date. |
The dividend
Fifteen years of raises, covered 1.57 times by cash — tested
Merck pays $0.85 a quarter, $3.40 a year, a yield of 2.3%, the lowest at any year-end in the last decade (the range was 2.5–3.5%). Dividends declared per share have risen every year since 2011, fifteen years in a row, after four flat years from 2007 to 2010. The raises have been modest and slowing: +5.8% in November 2022, then +5.5%, +5.2% and +4.9%. Last year's was announced on 18 November; this year's had not been announced when we wrote. Over ten years the dividend has grown about 6% a year.
| Test | Evidence | Result |
|---|---|---|
| 1. Cover on free cash flow | Last twelve months: $8.37bn of dividends against $14.75bn of free cash flow, 57%. 2025: 66%. Ten years 2016–25: 1.57× cover. | Pass |
| 2. The trend of that cover | Not covered in 2017 (113%) and 2020 (107%); comfortably covered since. Dividends plus buybacks used 94% of ten years' free cash flow. | Stable |
| 3. Paid from operations or from paper? | The dividend from operations; the deals partly from debt (from $24.8bn in 2016 to $53.8bn now). | ◆ Ops, deals on debt |
| 4. Balance-sheet room | Net debt ~$42.5bn, ~1.5× EBITDA before one-off charges; Aa3 / A+; $6bn undrawn revolver to 2031; $2.7bn due in 2027. | Pass |
| 5. What would force a cut | The payout is about 38% of underlying earnings. Earnings would have to fall by more than half and stay there, a cliff with no replacement at all, before the dividend was at risk. The CFO: "We remain committed to the dividend with the goal of increasing it over time." | Very unlikely |
| 6. The growth rate and its direction | +5.8%, +5.5%, +5.2%, +4.9%: slowing, as cash goes to deals and debt. We expect raises of 3–5% through the cliff years. | ◆ Slowing |
Our reading. This is the safest dividend of the three companies we analysed this week, with the lowest yield. Merck pays out less than 40% of what its business earns, so even a deep Keytruda cliff would not threaten it. The reason the yield is only 2.3% is the price, not the dividend: at the May 2025 low the same $3.24 a year then paid yielded 4.4%. An owner who bought then has done very well. A buyer today is paying for the pipeline, and the dividend is a small part of the return.
★ Valuation
What Merck is worth on the far side of the cliff, and what the price assumes about it
On today's earnings, Merck looks reasonably priced: 16–17 times, a little above the large-pharma average. The trouble is that today's earnings are the last of their kind. Valuing Merck means valuing 2030, after the cliff, and asking what the market will pay then.
Our method. We estimate earnings per share in 2030 (Merck's non-GAAP measure, before one-off acquired research), apply an exit multiple, discount 4.1 years at 10%, and add the dividends received on the way (about $12 a share in present value).
| Case | 2030 EPS | Multiple | Value today | What it means |
|---|---|---|---|---|
| The cliff bites | $7.00 | 11× | ~$65 | Biosimilars and the IRA price cut Keytruda by more than half by 2030; Qlex is held back in Europe; the bispecifics win lung cancer; the replacements fill a third of the gap. |
| Consensus ◆ | $9.82 | 16× | ~$120 | Analysts' own 2030 figure: flat through the cliff, as the replacements and Qlex offset the losses exactly. Valued at roughly today's multiple. |
| The pipeline wins | $11.50 | 18× | ~$150 | Qlex holds 40% of US use, the vaccine, Lipfendra and sac-TMT become large, and the market pays a premium for a company growing again after its cliff. |
The consensus case moves to about $105 at 14 times and $132 at 18 times; to $104 at $8.50 of 2030 EPS and $131 at $11.00. What is priced in? At $147.76, Merck must earn about $12.50 a share in 2030 if the market then pays 16 times, or about $11.15 at 18 times: 26% to 42% more than today's underlying earnings, on the far side of losing the patent on half the company. The price sits at our best case. It assumes the pipeline wins and the market rewards it.
Margin of safety. We cannot estimate Merck's 2030 earnings with the confidence our method asks for; this is the "uncertainty present" tier at best, which asks for a 40–50% discount to a central value. We will not ask for that, because it would mean a price Merck reached only in the panic of May 2025. But we will ask to pay no more than our central case for a business whose next five years depend on trials, courts and Washington. We would add near $115: a 3.0% yield, about 13 times 2027 consensus, and roughly where the shares were in February 2026, nine months ago.
Risks, lawsuits & controversies
Verified 14 November 2026 against the Q3 2026 10-Q, the 2025 10-K and news
Gardasil product liability. The US multidistrict litigation and state cases alleging injuries from Gardasil are resolved: Merck reached an agreement in October 2025, its conditions were met, and Merck says the cost was not material and "considerably less" than the expected cost of defence. Fewer than 15 cases remain outside the US.
Securities class action. Cronin v. Merck alleges that Merck misled investors about Gardasil demand in China between October 2023 and February 2025; the claims are unproven. The motion to dismiss is fully briefed, with oral argument on 14 December 2026; related derivative suits are stayed.
Government inquiries. Civil investigative demands from the US Justice Department: one (August 2025) under the False Claims Act about diversity programmes and federal-contract certifications, one (June 2024) about Medicaid price reporting and patient-assistance programmes for Steglatro and Januvia. Merck is cooperating.
Patents. Halozyme's claims against Keytruda Qlex: injunctions in Germany (December 2025) and the Netherlands (7 October 2026, covering Denmark and Italy and blocking launches in four more countries); hearings on 19 November (German appeal), 30 November (UK trial) and 2 December (Italy). In the US, the patent board found every challenged Halozyme claim unpatentable. Merck expects litigation over two extended Keytruda patents running to 2029.
Other. About 830 state cases over Dr. Scholl's talc products (a Schering-Plough legacy; Merck won a recent trial in Chicago). A RotaTeq antitrust class action and Bravecto consumer class actions are pending. Merck lost its constitutional challenge to the IRA on 24 August 2026. Its December 2025 agreement with the US government defers Section 232 pharmaceutical tariffs for three years.
| Test | Today | What would change our mind |
|---|---|---|
| Ivonescimab, FDA, 14 Nov 2026 | Decision pending | Approval matters less than the head-to-head trial against Keytruda in lung cancer (HARMONi-3). A clear win there would argue for the lower case. |
| Dividend, ~18 Nov 2026 | $0.85 a quarter | A raise of 4–5% is the base case; anything below 3% would say cash is tighter than we think. |
| Halozyme: Germany 19 Nov, UK 30 Nov, Italy 2 Dec | Injunctions in force | Wins for Merck would free Qlex in Europe before the EU patents end in 2031; losses would make the European shield thinner. |
| Q4 results and 2027 guidance, 2 Feb 2027 | 2026 sales $66.8–67.3bn | 2027 guidance that holds underlying EPS near $9 despite >$2bn of lost sales would support the consensus case. A guide below $8.50 would lean towards the lower one. |
| Qlex adoption | 9.7% of the family (Q3 2026) | Above 20% by the end of 2026 and on track for 30–40% by end-2027 would protect a large part of Keytruda past 2028. |
| Sac-TMT, FDA, 15 Jun 2027 | Priority review | Approval and a fast launch would add a real new franchise; a delay would push the replacement further out. |
Eighteen months ago, at $73.47, you could have bought one of the best-run drug companies in the world for about eight times its earnings, because the market had decided that the patent on its great medicine would take the company down with it. Since then the shares have doubled. It is worth saying what has not changed: Merck will earn about the same in 2026, before one-off items, as it did in 2025, and Keytruda's American patent still ends in 2028.
Give the business its full due. Keytruda is one of the most important medicines of the century, and the people who built it know more about treating cancer with the immune system than almost anyone. Merck has a sensible plan to protect it: move patients to an under-the-skin version patented until 2043, and build the next combinations on top of it. It has a new cholesterol pill that may become very large, a melanoma vaccine that cut the risk of relapse by 42%, a lung-disease medicine bought in 2021 that now sells nearly $3 billion a year, and an animal-health business that will be there in 2040. Its balance sheet is sound, and its dividend takes less than 40% of what it earns.
Now the rub. Half of what Merck earns depends on a patent with two years left, a government price that is expected to arrive a year later, and a new class of cancer drugs aimed squarely at its largest use. Against that, Merck has bought or licensed some $60 billion of science, of which one purchase has clearly paid so far. Management's "$70 billion" is what the pipeline could sell if everything works; it is not a forecast, and management says so. Analysts expect earnings to stay flat straight through the cliff. That would be a remarkable achievement. It is the price you would be paying for.
We value Merck at about $120 a share if the analysts are right and the market pays roughly today's multiple, and about $150 if the pipeline wins and the market rewards it. At $147.76 the price is at that better case. This is not a business we can value with confidence, and when we cannot, we prefer to pay for the middle of the range, not the top. We would add near $115, a 3% yield, where the shares traded in February, before the vaccine result and the record. If the pipeline keeps delivering, you will have paid a fair price for a great franchise. If it stumbles, you will not have paid for the stumble.
If you own Merck, there is no reason to sell a company with this balance sheet and this dividend; keep it, and watch Qlex adoption, the European patent cases and the 2027 guidance. If you do not, let the trials, the courts and Washington do some of the work first.
— The Buffett Lens. A patent is a moat with a date on it. Pay for what lies beyond the date, not before it.
Add Near $115A great franchise racing its own patent cliff, priced as if it had already won. ★ At $147.76, 16.6× 2027 consensus with flat earnings, the price is about 25% above our central value of ~$120 and at our best case (~$150), within a range of ~$65 to ~$150. Owners can keep it; new money should begin near ~$115 (3.0% yield). Dividend raise expected ~18 November; 2027 guidance on 2 February.



